K780872 is an FDA 510(k) clearance for the CYTOLOGY BRUSH. This device is classified as a Brush, Biopsy, Bronchoscope (non-rigid) (Class II - Special Controls, product code BTG).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 7, 1978, 100 days after receiving the submission on May 30, 1978.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 874.4680. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K780872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1978 |
| Decision Date | September 07, 1978 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | BTG — Brush, Biopsy, Bronchoscope (non-rigid) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |